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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Pfizer Proposes to Make Viagra Available in the UK Without a Prescription

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released a Pfizer proposal calling to make the popular erectile dysfunction drug sildenafil (more commonly known as Viagra) available without a prescription at UK pharmacies.

MHRA said it considers that “direct risks can be minimised to an acceptable level for Pharmacy supply of sildenafil 50mg tablets.”

Other ways to minimize those risks include Pfizer’s proposal that the drug only be made available for those over 18, and for patients with certain cardiovascular conditions and risk factors that might make them unsuitable for using the drug, they will be provided with instructions to consult a doctor.

“Patients can be assessed for suitability by a pharmacist and made aware of the risks, situations where supply is not appropriate and potential interactions with other drugs. The risks of indirect danger arising from missed diagnosis of underlying disease is minimised through the pharmacist using their professional judgement and the checklist to identify patients for whom the product is not suitable, and referring these patients to a doctor,” the proposal says.

In addition to the “low risk of direct danger and of intentional abuse” the proposal says those risks are “outweighed by the benefits that this route of supply can bring – by bringing a hard to reach group into healthcare environment with the potential to increase earlier identification of heart disease and also reducing the risks associated with use of counterfeits obtained via the internet.”